ISPE announced that the U.S. FDA’s Grace McNally will appear at the Society’s upcoming Lessons from 483s: Enhancing Efficiency, Quality and cGMP Compliance Conference. McNally will add her expertise to that of other industry and regulatory experts at the two-day event, which will review recent regulatory citations (FDA-483s) and provide guidance on how the citations can be avoided. This conference will give pharmaceutical professionals the vital insights into regulatory issues they need in order to avoid the costly and damaging consequences that can result from 483 citations, such as recalls and plant shutdowns.
Educational content will address 483s in the context of biotech, oral solid dosage processing and containment, and process validation. The conference, part of ISPE’s Facilities of the Future conference series, will take place in Tampa, FL February 27-28, 2012.
“As the technical voice of manufacturing and engineering in the pharmaceutical industry, ISPE is committed to presenting programs that facilitate relevant dialogue and the sharing of best practices among industry leaders, manufacturing experts, and leading regulators,” said ISPE’s new president and CEO Nancy Berg. “At a time when manufacturing operations are under tremendous pressures to improve effectiveness, deliver quality and reduce costs, ISPE is responding with new programs and conference formats that feature dynamic and focused session content. Our events are developed to deliver information, discussion and networking that lead to new ideas, problem-solving and process improvement concepts that, when applied, have positive bottom-line results.”
The event will feature three keynote presentations from experts in the pharmaceutical industry, including:
* Michael Lewis, president, Eisai Product Creation Systems, USA
Small Molecule Researcher's View to Facilities of the Future
* Andy Skibo, executive vice president, MedImmune, USA
Biotech Perspective on Cost Effective Operations
* Chaz Calitri, vice president, global engineering, Pfizer, USA
2020 Vision - the Next Generation of Manufacturing Facilities
The conference will contain three distinct tracks:
* A Biotech track led by Wendy Lambert, director pharma business support, Abbott, USA, Steven Miller, director, process eng, MedImmune, USA, and Andrew Skibo, executive vice president, operations, MedImmune, USA.
* An Oral Solid Dosage Processing and Containment track led by Paul Egee, product manager, IMA North America, USA, Alan George, product manager, ILC Dover Inc., USA, and Raymond Scherzer, PE, PM SET, LLC, USA.
* A Process Validation track led by Joanne Barrick, advisor, global validation support, Eli Lilly & Co., USA.
For more information on this conference, including detailed agendas and registration information, visit www.ISPE.org/FacilitiesConference.
ISPE will also hold a related training course immediately following this conference. The course, titled “Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline Guide” will be held February 29 – March 1, 2012 at the same venue. More information on this training course can be found at www.ISPE.org/2012-Tampa-Training.
ISPE, the International Society for Pharmaceutical Engineering, is a not-for-profit Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. Visit www.ISPE.org for additional Society news and information.